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NCT01624493

NCT01624493
Withdrawn Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

For the early phase (Phase I) of the trial:

  • You have been diagnosed with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has been confirmed by a lab test, including all types and a type called carcinosarcoma.

For the later phase (Phase II) of the trial:

  • You have been diagnosed with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer confirmed by a lab test (not including carcinosarcoma or mucinous carcinoma types).
  • Your cancer came back between 4 and 9 months after your first round of chemotherapy, or between 4 and 12 months after a second round of chemotherapy that included a platinum-based drug (cisplatin or carboplatin).
  • Your cancer has gotten worse since your last platinum-based chemotherapy, as shown by blood tests or scans.
  • Your response to treatment can be measured using blood tests or scans.
  • If you have fluid build-up in your abdomen or around your lungs, your cancer must be measurable by scan.
  • You are able to start the study treatment within 7 days of being assigned to a treatment group.

Who may not be able to join:

  • Your ovarian cancer is a non-epithelial type, or your tumour is considered "borderline" (low risk of spreading).
  • You have had more than two different chemotherapy treatments for ovarian cancer in the past (not counting hormone therapy or biological treatments).
  • You have had chemotherapy for a different type of cancer in the past (though for Phase II, treatment more than 10 years ago may be acceptable — confirm with trial site), especially if it involved high-dose chemotherapy or a stem cell/bone marrow transplant.
  • You had chemotherapy within the last 20 days.
  • You had hormone therapy or biological therapy within the last 28 days.
  • You are currently receiving another experimental treatment or any other cancer treatment.
  • You are currently taking blood-thinning or antiplatelet medicines such as clopidogrel, ticlopidine, or persantin.
  • You had radiotherapy within the last 21 days, or radiotherapy that covered more than 15% of your bone marrow.
  • You still have side effects from previous chemotherapy that are more than mild in severity.
  • You have cancer that has spread to your brain or the lining around your brain or spinal cord.
  • You have had another type of cancer in the last 3 years, with some exceptions such as certain early-stage skin cancers, early cervical changes (carcinoma in situ), or a specific early-stage womb cancer (confirm with trial site).
  • You have untreated or uncontrolled heart problems, or have had a heart attack, heart failure, or serious irregular heartbeat within the past year, or have a history of certain heart conduction problems.
  • You have had a stroke or a mini-stroke (TIA) within the last 6 months.
  • Your blood pressure is poorly controlled (above 150/100 mmHg), even after two separate readings — blood pressure medication is allowed if it brings your readings within the acceptable range.
  • You have had a blood clot in a vein or lung within the last 6 months, or a blood clot in an artery within the last 12 months.
  • You are taking full-dose blood-thinning medication such as warfarin, other oral anticoagulants, or heparin injections (low-dose preventative heparin and low-dose aspirin of 325 mg or less per day are acceptable).
  • You have a serious active infection, including active hepatitis B, hepatitis C with abnormal liver results, or HIV.
  • You have a serious medical or mental health condition that could make it difficult to follow the trial treatment plan.
  • You have had a major operation, open biopsy, or serious injury within the last 28 days.
  • You are pregnant, breastfeeding, or not using reliable contraception — if you could become pregnant, you must have a negative pregnancy test within 7 days before joining.
  • Your doctors estimate that you have less than 12 weeks to live.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Withdrawn
Phase
Phase 2
Sponsor
Hoosier Cancer Research Network
Registry
clinicaltrials_gov
Start date
1 October 2012
Est. completion
1 July 2014

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Phase I: Determine Maximum Tolerated Dose for Patients; Phase II: Determine Objective Response Rate in Patients

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov